Trunk Task-oriented Training Combined With Functional Electrical Stimulation in Spinal Cord Injured Individuals
- Conditions
- Spinal Cord Injuries
- Interventions
- Other: Trunk-oriented task training combined with functional electrical stimulationOther: Trunk-oriented task training alone
- Registration Number
- NCT05196204
- Lead Sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Brief Summary
The objectives of the study are to evaluate trunk task-oriented training combined with function electrical stimulation (FES/T-TOT) efficacy on sitting balance and functional independence, and to understand the mechanisms of neuroplasticity that would improve functional independence following FES/T-TOT in individuals with spinal cord injury.
- Detailed Description
After obtaining their consent, participants will undertake evaluations at different times:
1. Assessment 3 weeks prior to training
2. Assessment 1 week prior to training
3. Training over 12 weeks
4. Assessment 1 week after training
5. Assessment 1 month after training (follow-up)
Each assessment will be divided in 2 sessions and data will be collected over 2 days, at one session per day. The assessment will consist of:
* Session 1 (at Neuro-Concept clinic) will include presentation of the study and the obtention of written consent, clinical (modified Reaching test and muscle strength), quality of life and functional independence assessments.
* Session 2 (at IURDPM in Dr. Barthélemy's laboratory) will include postural control, corticospinal and cortical assessments.
After the initial assessment, the participants with spinal cord injury will realize 36 sessions of trunk task-oriented training alone or combined with function electrical stimulation (3 times a week for 12 weeks).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 45
- Level of spinal cord lesion between C6/C7 and T10
- At least, 6 months post-injury
- Be considered as AIS A, B, C or D
- Be able to sit without support for 15 seconds
- Be able to provide informed consent in English or in French
- To have cognitive deficits
- To wear a corset
- To have personal or family history of epilepsy
- To have suffered moderate or severe traumatic brain injury
- To have cochlear implant
FOR CONTROL PARTICIPANTS
Exclusion Criteria:
- To have orthopedics problems
- To have cognitive deficits
- To have neurological problems
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Trunk-oriented task combined with functional electrical stimulation training group Trunk-oriented task training combined with functional electrical stimulation This group will be formed with participants with spinal cord injury. This group will perform 12 weeks of trunk-oriented task training combined with functional electrical stimulation. Trunk-oriented task training group Trunk-oriented task training alone This group will be formed with participants with spinal cord injury. This group will perform 12 weeks of trunk-oriented task training.
- Primary Outcome Measures
Name Time Method Change in Function in Sitting Test Before and after the 12-week trainings and 1-month follow-up This test evaluates the sitting balance via 14 everyday functional activities rated from 0 to 4 according to the reactions of the participants.
Change in modified Functional Reach Test Before and after the 12-week trainings and every 4-weeks during the training period This test evaluates the ability for each participant to realize a lateral and anterior trunk flexion in order to observe the maximum distance reached.
- Secondary Outcome Measures
Name Time Method Modification of the excitability of the reticulospinal pathway using the acoustic startle response Before and after the 12-week trainings and 1-month follow-up A tone will be triggered just before the reaching movement. The EMG responses of trunk muscles will be analyzed.
Change in EMG activation pattern of electromyographic activity of muscles in the trunk Before and after the 12-week trainings and 1-month follow-up during reaching and pointing tasks
Change in the center of pressure excursion Before and after the 12-week trainings and 1-month follow-up during reaching and pointing tasks
Modification of the excitability of the vestibulospinal pathway using galvanic vestibular stimulation Before and after the 12-week trainings and 1-month follow-up Vestibular responses induced by GVS will be identified in the trunk muscles
Trial Locations
- Locations (2)
Neuro-Concept Inc
🇨🇦Montreal, Quebec, Canada
Neuromobility lab
🇨🇦Montréal, Quebec, Canada